NCT00656201

Brief Summary

The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 20, 2011

Completed
Last Updated

September 22, 2011

Status Verified

September 1, 2011

Enrollment Period

5.3 years

First QC Date

April 4, 2008

Results QC Date

June 27, 2011

Last Update Submit

September 20, 2011

Conditions

Infertility

Keywords

InfertilityIn vitro fertilizationEmbryo transferCrinoneIntramuscular ProgesteroneProgesterone support

Outcome Measures

Primary Outcomes (1)

  • Percentage of Pregnant Patients After IVF Treatments

    Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval

    16 weeks

Study Arms (2)

Crinone 8% Vaginal Gel

ACTIVE COMPARATOR

Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.

Drug: Crinone 8% Vaginal Gel

Intramuscular Progesterone

ACTIVE COMPARATOR

Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy. .

Drug: Intramuscular Progesterone

Interventions

Crinone 8% Vaginal GelDRUG

Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.

Also known as: IVF-ET, Pregnancy, luteal phase support, Crinone, Intramuscular progesterone, vaginal progesterone
Crinone 8% Vaginal Gel
Intramuscular ProgesteroneDRUG

Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.

Also known as: Other Names:, IVF-ET, Pregnancy, luteal phase support, Crinone, vaginal progesterone
Intramuscular Progesterone

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH \< 15 mIU/ml
  • Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

You may not qualify if:

  • Women who have had more than 3 previous IVF/ET cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Yanushpolsky E, Hurwitz S, Greenberg L, Racowsky C, Hornstein M. Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study. Fertil Steril. 2010 Dec;94(7):2596-9. doi: 10.1016/j.fertnstert.2010.02.033. Epub 2010 Mar 27.

    PMID: 20347079RESULT

MeSH Terms

Conditions

Infertility

Interventions

CrinoneVaginal Creams, Foams, and JelliesPregnancy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and SuppliesReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Results Point of Contact

Title
Elena Yanushpolsky, MD
Organization
Brigham and Women's Hospital
lgreenberg@partners.org
617-732-4648

Study Officials

  • Elena H Yanushpolsky, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ob/Gyn, BWH and Harvard Medical School

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

July 1, 2003

Primary Completion

November 1, 2008

Study Completion

July 1, 2009

Last Updated

September 22, 2011

Results First Posted

September 20, 2011

Record last verified: 2011-09

Locations

US(1)